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EPS Bio Technology Easy Pain Supreme User Manual

Self-monitoring blood glucose system
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Self-Monitoring Blood Glucose System
User's Manual
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Summary of Contents for EPS Bio Technology Easy Pain Supreme

  • Page 1 ® Easy Pain Supreme Self-Monitoring Blood Glucose System User’s Manual...
  • Page 2 EPS Bio Technology Corp. 2F, No.49-2, Lane 2, Guang-Fu Rd., Sec. 2, Hsinchu City, Taiwan 300 TEL：+886-3-5752522 FAX：+886-3-5752552 E-mail：info@epsbio.com.tw Rev: A04 P/N: 7180002 Please read this User’s Manual thoroughly before use.

  • Page 3: Table Of Contents

    Table of Contents Introduction Measuring Principle Intended Use Important Information Standard Accessories Optional Accessories Components Before Testing Battery Installation Presetting Coding Your Meter Testing Fingertip Blood Sampling Step-by-Step Test Procedure Reviewing Stored Records Checking the System I. Use the check strip II.
  • Page 4 I. Thermometer Setting II. Alarm Setting III. Beep Setting IV. Clock Setting Cleaning and storing the Meter Specifications Limitations of the Procedure Performance Characteristics Accuracy Specifications Displaying Messages Troubleshooting Error Messages Warning Messages Device Information Warranty...

  • Page 5: Introduction

    Introduction Thank you for using the Easy Pain Supreme Self-Monitoring Blood Glucose System. We design his system for medical care on diabetes. The test results can help you determine the effects of food, exercise and diabetes medications. We design this...

  • Page 6: Measuring Principle

    EPS Bio Technology Corp. office or authorized distributor during business hours Measuring Principle We design The Easy Pain Supreme Self- Monitoring Blood Glucose System to allow you to get fast measurement of blood glucose by using an electrochemical biosensor technology.

  • Page 7: Intended Use

    The meter will measure the glucose concentration and display on the screen after 25 seconds. Intended Use Easy Pain Supreme Self-Monitoring Blood Glucose System is self-test IVD medical equipment. You may use it for both home testing and for professional use to monitor the blood glucose (β...
  • Page 8 • Incorrect results may occur when performing the test. When you are not feeling well, please contact your healthcare professional. • Keep the meter clean and always store it in a safe place. Protect from direct sunlight to ensure a longer lifespan. •...
  • Page 9 • Indicate the date you open the vial. Discard all unused strips after 90 days from open date. The strips are for single use only. • Warning for potential biohazard: Healthcare professionals using this system on multiple patients should handle the all products or objects contact with human blood carefully for fear of transmitting viral disease, even after cleaning.

  • Page 10: Standard Accessories

    Standard Accessories 1. Wallet 2. User's Manual 3. Self-Test Log Book 4. Warranty Card 5. EPS Blood Glucose Meter 6. Instructions 7. Lancing Device 8. Code Card 9. Check Strip 10. Quick Reference Guide 11. EPS Blood Glucose Test Strip x 10 pcs Alkaline Batteries 1.5V (AAA) x 2...

  • Page 11: Optional Accessories

    Optional Accessories 1. Glucose Normal Control Solution 2. Glucose High Control Solution...

  • Page 12: Components

    Components...

  • Page 14: Before Testing

    Before Testing Battery Installation The device uses 1.5V (AAA) x2 alkaline batteries {included}. You may use the battery power for over 1000 measurements. Install the batteries when you want to start to use the meter or replace with new batteries when the"...
  • Page 15 3. Close battery cover Slide the battery cover back in place until it clicks securely. The LCD display will show "no CODE" when you first time install the batteries. Please code your meter correctly. Caution: 1. The meter will delete earlier records after you replace Batteries.

  • Page 16: Presetting

    Presetting You need to preset time and date when you install or replace the batteries. Please preset your device with the following procedures. 1. Entering setting mode Press "B" button, the meter will enter the setting mode and the display shows the “year” at the center of LCD display. A.
  • Page 17 After confirming, the first 2-digit (month) at the left up corner of LCD will blink. Press 'A' button to adjust months, and press 'B' button to confirm. After confirming, the blinking area will go to next 2-digits (day). Press "A" button to adjust days, and press °B°...
  • Page 18 times until symbol "AM" changes to symbol "PM". Press" B" button to confirm. After confirming, the blinking area will go to the next 2-digits (minute). Press" A" button to adjust the minutes, then press" B" button to confirm the setting. Caution: If you want to skip adjusting hours or minutes, press "B"...
  • Page 19 Selecting the Unit of Measurement You will see the unit-setting mode after the time setting confirmation. The LCD will show the "SCL" and “mg/dL " message. Press 'A' button to switch to the “mmol/L unit. Press “A" key again to switch back to the “mg/dL unit.

  • Page 20: Coding Your Meter

    Coding Your Meter Caution: When you use a new vial of strips you should use the code card to code the device to get the correct reading. Check the code number Check that the code on the code card and vial are identical.
  • Page 21 Caution: 1. Do not discard the code card until you use all strips in the same vial. 2. You will see an error message "FAL" and CODE icon if you did not complete previous coding process. Repeat the steps above again to complete the coding process.

  • Page 22: Testing

    Testing Read the test strip instructions carefully before testing. Make sure you have all items needed to test. Before blood sampling, wash your hands with soap and warm water. Rinse and dry thoroughly.
  • Page 23 1. Unscrew the Lancing Device front cap 2. Insert the lancet Insert the lancet into the lancing device firmly and twist off the protective cover. 3. Recap the front cap 4. Select the desired penetration depth...
  • Page 24 Select 1-2 for soft or thin skin, 3 for average skin, 4-5 for thick or calloused skin. Upper gear 1. Pull on the sliding barrel of the lancing device until it clicks and then release. 2. Now the device is ready. 3.

  • Page 25: Fingertip Blood Sampling

    1. Take one strip out and recap the vial. 2. The device will turn on when you insert the strip into the slot. 3. You will see the code number briefly. Make sure the displayed code is identical to the code on the vial.
  • Page 26 Caution: 1. Clean testing area thoroughly for correct reading. 2. To avoid infection, do not share the lancing device and lancet with other people. The sterile lancet is for single use only. Do not reuse the lancets. 3. You should discard the used strip, lancet, and alcohol swab.

  • Page 27: Step-By-Step Test Procedure

    Step-by-Step Test Procedure 1. Sampling the blood droplet Use the lancing device to get a droplet of blood from fingertip. Apply blood to the strip...
  • Page 28 When the display flashes 〝 〞, apply the blood droplet to blood collection area on strip. The strip will siphon the blood into the reaction zone. The device will begin to measure. Please notice that the blood should fill the reaction zone.
  • Page 29 3. Display the reading You will see the result in 25 seconds and the meter will record results. If there are more than 100 records, the device will erase your oldest record stored, and replace it with the newest result. 4.
  • Page 30 Caution: 1. The strip is for single use only. Do not reuse it. 2. The measuring range is between 1.7 mmol/L to 33.3 mmol/ (30 mg/dL to 600 mg/dL). The display will prompt 'LO' if the reading is lower than 1.7 mmol/L ( 30 mg/dL ) or "HI"...
  • Page 31 Note: Expected results for non-diabetic, non-pregnant adult: a. Fasting values: 70 mg/dL to110 mg/dL(3.9 mmol/L to 6.1 mmol/L). b. Two hours after meals: less than 120 mg/dL(6.7 mmol/L). If your test result is not consistent with your symptoms or if your blood glucose result is less than 60 mg/dL (3.3 mmol/L) or higher than 240 mg/dL (13.3 mmol/L), you should contact your healthcare professional .

  • Page 32: Reviewing Stored Records

    Reviewing Stored Records The device will store 100 sets of records with a time & date stamp. 1. Entering memory mode Press “A " button to enter the memory mode if there is no test result in memory. LCD will show "--- MEM". You always see the latest records when you look for old records.
  • Page 33 3. Delete the record Press " A " button for more than 3 seconds, the LCD will show "dEL" instead of the current reviewing record. If you still press "A" button and do not release, you will erase the currently viewed record.
  • Page 34 5. Closing the memory mode 1. Press 'A' button to close the memory mode. 2. At memory mode, the meter will shut down after minutes if you don't press any key. 3. When you don’t press any key for operation, the meter will shut down in 5 minutes.

  • Page 35: Checking The System

    Checking the System I. Use the check strip Use the check strip to check the meter's functions. Please store the check strip safely. 1. Insert the check strip Insert the check strip into the slot 2. Checking the message on the screen a.

  • Page 36: Use Control Solutions

    Remove the check strip and store in a safe location. II. Use control solutions Use control solutions and test strips to check whether the system is working properly. 1. You should use control solutions when: Use the Glucose meter for the first time. You open a new vial of test strips.
  • Page 37 2. Procedure When you use a new vial of test strips, you must code the meter with the new code card packed in the box for an accurate blood glucose test result. Please check that the CODE number on the code card matches that on the vial of blood glucose test strips.
  • Page 38 Step l: 1. Insert Test Strip. 2. Remove a test strip from the vial and recap the vial. 3. Insert the test strip into the slot of the meter, and the meter will turn on. 4. Make sure the code number on the display matches that on the test strip vial.
  • Page 39 Step 2: 1. Apply Sample. When you see the 〝 〞 symbol, shake the glucose control solution well. 2. Hold the glucose control solution vial; discard the first drop of control solution. 3. Then squeeze a drop of solution slowly onto a plastic plate, remove the solution vial and recap.
  • Page 40 3. Understanding the Reading If the reading of your test falls within the expected range printed on the strips vial labels, then the test strip and the glucose meter are working together correctly. The results of your blood glucose tests are reliable. If the reading falls outside the expected range, your meter may not be working properly.
  • Page 41 You may see acceptable control ranges for glucose control tests in the table below: Acceptable Control Ranges Normal Control 5.3-8.0 mmol/L 96- 144 mg/dL High Control 15.6-23.3mmol/L 280- 420 mg/dL...

  • Page 42: The Advanced Meter Setting

    The Advanced Meter Setting I. Thermometer Setting Press 'A' and “B’ buttons at the same time more than 3 seconds. The meter will go into Centigrade Thermometer mode. Press "B" button, the meter will change the temperature reading to Fahrenheit. Press "B"...
  • Page 43 2. Press "B" button when LCD displays " OFF ", the meter will change alarm mode into Beep Setting Mode. 3. Press " B" button when LCD displays "On", the first 2-digits of time (hour) will blank. Press " A" button to adjust the hours. 4.

  • Page 44: Beep Setting

    III. Beep Setting You will see the Beep Setting Mode after confirming Alarm Setting. Press 'A' button to switch the " On " "OFF " at the center of LCD. Press "B' button to confirm.

  • Page 45: Clock Setting

    IV. Clock Setting You will see the Clock Mode, after confirming the beep setting. 1. You will see 2-digits (second) at the center, 2-digits (month) and 2-digits (day) at the top left corner, 2-digits (hour) and 2-digits (minute) at the top right corner. 2.

  • Page 46: Cleaning And Storing The Meter

    Cleaning and storing the Meter I. Cleaning the Meter 1. The Blood Glucose Meter does not require special cleaning. Keep the strip slot away from dirt, dust, bloodstains, and water stains. 2. Clean your meter carefully with moist lint-free cloth or dampened cotton swab, if the meter gets dirty outside II.

  • Page 47: Specifications

    Specifications Limitations of the Procedure We design Easy Pain Supreme Blood Glucose Test Strips only for use with fresh capillary whole blood sample 1. DO NOT use serum or plasma samples. 2. DO NOT use neonatal blood samples. 3. Extreme humidity may affect the results. A relative humidity over than 90 ﹪...
  • Page 48 incorrect high readings B .Hematocrit levels greater than 55﹪may cause incorrect low readings. If you do not know your hematocrit level, consult your healthcare professional. 8. The substances listed below may affect the test results, depending on the concentration. Acetaminophen ≧ 1.0 mmol/L or 15 mg/dL Gentisic Acid ≧...
  • Page 49 You should not test critically ill patients with home-use blood glucose meters. 12. You should carefully check cholesterol and triglyceride levels for correct meter results. 13. Recent studies prove EMI can cause electronic medical device performance degradation and could lead to inappropriate therapy. 14.

  • Page 50: Performance Characteristics

    Performance Characteristics The measurement range of the Easy Pain Supreme is between 1.7 mmol/L to 33.3 mmol/L (30 to 600 mg/dL). The performance of the test strips is validated both in laboratory and in clinical tests. Precision We measured Blood Glucose System with both venous blood and control solution in the laboratory.

  • Page 51: Accuracy

    Accuracy We assessed the Blood Glucose System with the YSI 2300 Analyzer, which was for laboratory use. We had 213 subjects with diabetes at three independent clinics. We designed a plot of the EPS capillary data versus YSI plasma data for the regression statistics.

  • Page 52: Specifications

    Specifications Easy Pain Supreme Brand Name Blood Glucose Meter 30~600 mg/dL Range (1.7~ 33.3 mmol/L) Response time 25 seconds Memory sets 100 sets Temp. 10°C ~40°C (50°F ~104°F) Operating condition Relative R.H. ≦ 90% Humidity ≧2.0 μL Blood amount Sample...

  • Page 53: Displaying Messages

    Displaying Messages Troubleshooting 1. If you cannot turn on the meter. • Check you install the batteries correctly. • Power is low. Replace the batteries. 2. No display after inserting the strip • Check you insert the strip correctly .You should face the graduated blue color side.
  • Page 54 5. No measuring after faking a blood sample • Check the reaction zone window and the blood amount inside. The reaction zone should be fully red for correct test result • Check you insert the strip correctly. LO or Hl level •...

  • Page 55: Error Messages

    Error Messages Code transmission failure Action Re-insert the code card. If “Err” appears consistently, contact local dealer for repair. Humidified strips Action Replace with a new strip. Low power Action Replace with new batteries.
  • Page 56 System fault Action Replace the batteries first. If Err appears again, contact local dealer for repair. System fault Action Replace the batteries first. If Err appears again, contact local dealer for repair.

  • Page 57: Warning Messages

    Warning Messages The “Ht” and thermometer icon appears. Operating temperature is too high. Action Relocate the meter to working environment between 10℃~ 40℃ (50℉ ~104℉). It alerts you that an incorrect result may occur if test continues. The “Lt” and thermometer icon appears.
  • Page 58 Test result is higher that 600 mg/dL (33.3 mmol/L) Action Test again. If the result is still the same, please contact your healthcare professional immediately. The test result is lower than 30 mg/dL (1.7 mmol/L) Action Test again. If the result is still the same, please contact your healthcare professional immediately.

  • Page 59: Device Information

    Device Information Easy Pain Supreme SMBG System. Easy Pain Supreme Blood Glucose Test Strips. Easy Pain Supreme Blood Glucose Meter. Manufacturer: EPS BIO TECHNOLOGY CORP. 2F, No.49-2, Lane 2, Guang-Fu Rd., Sec. 2, Hsinchu City, Taiwan 300 TEL：+886-3-5752522 FAX：+886-3-5752552 E-mail：info@epsbio.com.tw http://www.epsbio.com.tw...

  • Page 60: Warranty

    Please read Easy Pain Supreme User’s Manual before operation. If you have any questions and/or need help, please contact as follows: Within the U.S.A., call Toll-Free: 1-888-216-5888 (Pacific Time, Mon-Fri 9:00AM~5:00PM) Outside the U.S.A, call your authorized representative or write to: Customer Service E-mail: info@epsbio.com.tw...

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